(294 days)
ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
ELITech Clinical Systems GLUCOSE PAP SL is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes three medical devices seeking 510(k) clearance: ELITech Clinical Systems GLUCOSE PAP SL reagent, ELITech Clinical Systems ELICAL 2 calibrator, and ELITech Clinical Systems ELITROL I and ELITROL II controls. The submissions focus on demonstrating substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study data presented for each device, structured according to your requested information:
1. ELITech Clinical Systems GLUCOSE PAP SL reagent
This device is a glucose reagent used for quantitative determination of glucose in human serum and plasma. The submission compares its performance to the ABX PENTRA GLUCOSE PAP CP predicate device.
- 1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | ELITech Clinical Systems GLUCOSE PAP SL (Reported Performance) | Predicate Device (ABX PENTRA GLUCOSE PAP CP) |
|---|---|---|---|
| Intended Use | Quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care. | For quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care. | For quantitative determination of glucose in serum and plasma. |
| Indication(s) for Use | Diagnosis and treatment of carbohydrate metabolism disorders. | Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma). | Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma). |
| Assay Protocol | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). |
| Composition | Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase, Peroxidase, Sodium azide. | Identical composition: Phosphate buffer (pH 7.4) 13.8 mmol/L, Phenol 10 mmol/L, 4-Aminoantipyrine 0.3 mmol/L, Glucose oxidase ≥ 10 000 U/L, Peroxidase ≥ 700 U/L, Sodium azide |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.